Visken® (Visken®)

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Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substancePindololPindolol
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  • Visken®
    pills inwards 
    Egis Pharmaceutical Plant OJSC     Hungary
    • Dosage form: & nbsppills
    Composition:Each tablet contains 5 mg active substance pindolol, Excipients: magnesium stearate, povidone, talc, microcrystalline cellulose, mannitol.
    Description:
    White or grayish-white round, flat tablets in the form of a disc with a bevel, on one side with engraving VISKEN, odorless or with a weak characteristic smell. A slight unevenness of the surface of the tablets is allowed.
    Pharmacotherapeutic group:Beta-blocker with SMA
    ATX: & nbsp

    C.07.A.A.03   Pindolol

    Pharmacodynamics:
    Pindolol is a lipophilic non-selective beta-adrenoreceptor blocker that has its own sympathomimetic activity (SMA). Pindolol partially excites β1 and β2 receptors has a particularly strong effect on β2 receptors.
    Mechanism of action:
    Pindolol is a competitive inhibitor of beta-adrenergic receptors in the heart, bronchi and smooth muscle, with a pronounced CMA. The membrane-stabilizing effect of this drug has no clinical significance. In patients with predominant sympathetic activity pindolol reduces the heart rate and cardiac output, but only slightly reduces the heart rate (HR) at rest. Relatively weakly suppresses the acceleration due to physical activity of the heart rhythm, reduces myocardial contractility, and also slightly slows the atrial-ventricular excitation. Pindolol increases the resistance of the respiratory tract.
    Like other beta-blockers, pindolol reduces blood pressure (BP), heart rate and heart rate, which leads to a decrease in oxygen consumption by the myocardium. By lowering the heart rate and corresponding lengthening of the diastole pindolol improves blood supply and oxygenation of areas of the myocardium with disturbed blood flow. Thanks to this action pindolol reduces the incidence of angina attacks and increases physical activity.
    In connection with the partial excitatory action on β2smooth muscle receptors pindolol has a clinically significant vasodilator effect. With arterial hypertension, this drug reduces the increased total peripheral vascular resistance and thus maintains or even improves the blood supply of various organs and tissues.
    Generally pindolol does not have an undesirable effect on plasma lipoprotein levels, even with prolonged use of the drug.
    Pharmacokinetics:
    The rapid and almost complete (> 95%) absorption and insignificant (13%) metabolism of the "first passage" account for the high (87%) bioavailability of pindolol.
    The maximum concentration of the drug in the blood plasma is reached 1 hour after ingestion.
    Pindolol has a linear pharmacokinetics in the range of 5 to 15 mg.
    Approximately 40% of the absorbed active substance binds to blood plasma proteins. The apparent volume of distribution is 2-3 l / kg.
    Due to lipophilic properties pindolol can penetrate the blood-brain barrier.
    Pindolol is metabolized to inactive metabolites in the liver.
    The final half-life is approximately 3-4 hours. Approximately 30-40% of the administered dose is excreted unchanged in the urine, and 60 to 70% is excreted by the kidneys and liver in the form of inactive metabolites. The clearance of pindolol from the entire body is 500 ml / min.
    Pindolol penetrates the placental barrier and is excreted in small amounts into breast milk. The ratio of the concentrations of the substance in the blood of the umbilical cord and the mother's blood is 0.7.
    The ratio of concentrations of pindolol in milk and maternal blood is 1.6.
    Indications:
    Arterial hypertension (monotherapy or (if necessary) in combination with other antihypertensive drugs).
    Stable angina as a monotherapy or in combination with other antianginal agents (prevention of seizures).
    Nadzheludochkovye rhythm disturbances: supraventricular tachycardia, ciliary tachyarrhythmia, supraventricular and ventricular extrasystole, extrasystole caused by physical exertion or digitalis preparations.
    Atrial fibrillation or flutter.
    Hyperkinetic cardiac syndrome.
    Contraindications:
    Hypersensitivity to pindolol or any other component of the drug Acute heart failure, chronic heart failure during decompensation.
    "Pulmonary" heart.
    Pronounced bradycardia (heart rate less than 40 beats per minute).
    Atrioventricular blockade of II and III degree, sinoatrial block.
    Bronchial asthma, chronic obstructive pulmonary disease.
    Syndrome of weakness of the sinus node.
    Cardiogenic shock.
    Arterial hypotension (systolic blood pressure less than 90 mm Hg) Severe renal dysfunction.
    Angina of Prinzmetal.
    Diabetes mellitus with ketoacidosis (see p.See also "Special instructions")
    Occlusal diseases of peripheral vessels (complicated by gangrene, "intermittent" lameness or pain at rest)
    Simultaneous administration of monoamine oxidase inhibitors (MAO) (see section "Interaction with other drugs").
    Simultaneous use with "parenteral blockers" of "slow" calcium channels such as phenylalkylamines (verapamil) or benzothiazepines (diltiazem) (see section "Interaction with other drugs")
    Age to 18 years (effectiveness and safety not established).
    Carefully:
    Atrioventricular blockade of the first degree, chronic heart failure, pheochromocytoma, Raynaud's syndrome, myasthenia gravis, thyrotoxicosis, depression (including history), psoriasis, hepatic insufficiency, chronic renal failure.
    Pregnancy and lactation:
    Clinical studies of pindolol in pregnancy are not available.
    In clinical studies of other beta-blockers, no fetotoxic effects were detected.
    For newborns, whose mothers received pindolol, it is necessary to establish a careful observation for a period of 2 to 5 days because of the possibility of developing bradycardia and hypoglycemia, presumably associated with blockade of beta-adrenergic receptors. A small amount of pindolol is excreted in breast milk. Although pindolol, falling in this way into the body of a newborn, does not pose a danger to him, caution should be exercised during breastfeeding, as side effects of beta-blockers (bradycardia, etc.) are possible.
    In this regard, Vicin should not be taken during pregnancy and breastfeeding, except when the benefit to the mother justifies the possible risk to the fetus and / or the child.
    Dosing and Administration:
    Tablets are taken orally.
    The dose should be selected for each patient individually.
    Arterial hypertension
    The recommended initial daily intake for adults is 5 mg twice daily. The usual maintenance dose is 10 - 30 mg per day for 2 - 3 doses. The daily dose should be increased gradually at weekly intervals until the desired antihypertensive effect is achieved. The maximum daily dose is 30 mg.The effect of the drug can be observed from the first week of its use, but the pronounced therapeutic effect develops after 3-4 weeks of treatment.
    Angina pectoris
    5 - 20 mg per day for 2 - 3 admission.
    Heart rhythm disturbances:
    15 - 30 mg per day for 2 - 3 admission.
    Hyperkinetic cardiac syndrome 5 - 20 mg per day for 2 - 3 admission.
    Elderly patients
    Elderly patients can be given the usual dose of the drug.
    Children
    Data on the use of the drug is not present in children.
    Impaired liver and kidney function
    With mild or moderate violations of the liver or kidney correction of the dose is not required. However, with a pronounced impaired liver function, there may be a need to reduce the dose, and in severe renal failure, the drug is contraindicated.
    Side effects:
    Pindolol is usually well tolerated. Possible weak transient side effects, which are similar to the side effects of other beta-blockers.
    Central nervous system: asthenia, fatigue, dizziness, headache, sleep disturbance, less often - depression, hallucinations, decreased potency, insomnia, nightmarish dreams, weakness, drowsiness, rarely: myasthenia gravis, paresthesia in
    limbs (in patients with "intermittent" lameness and Raynaud's syndrome), decreased libido, anxiety, confusion, tremor.
    From the sense organs: rarely: impaired vision, decreased secretion of tear fluid, conjunctivitis.
    The cardiovascular system: sinus bradycardia, orthostatic hypotension, heart failure, palpitations, arrhythmias, weakening of myocardial contractility, chest pain, lowering blood pressure.
    In very rare cases, violations of myocardial conductivity, atrioventricular blockade (up to the development of complete transverse blockade and cardiac arrest) are possible;
    Strengthening of pre-existing violations of peripheral circulation (manifestation of angiospasm), cooling of the lower limbs, Raynaud's syndrome.
    Respiratory system: very rarely - dyspnoea with physical exertion. Even less often - laryngo- and bronchospasm (even in the absence of obstructive pulmonary disease). Nasal congestion, difficulty breathing.
    The digestive system: complaints of abnormalities of the stomach and intestines; mostly nausea, vomiting, abdominal pain and diarrhea.Dryness of the oral mucosa, impaired liver function (dark urine, icteric sclera or skin, cholestasis), taste change.
    Musculoskeletal system: muscle spasms and tremors, arthralgia.
    Endocrine system: hypoglycemia (in patients receiving insulin), hyperglycemia (in patients with insulin-dependent diabetes mellitus). The drug reduces glucose tolerance in diabetes mellitus. It is difficult to normalize the blood glucose level. Reduces the level of high-density lipoprotein cholesterol and increases the level of triglycerides.
    From the skin: In rare cases, changes in the skin, erythema and exanthema are observed. Psoriasis-like skin reactions, exacerbation of psoriasis, reversible alopecia, increased sweating.
    Allergic reactions: itching, skin rash, stinging.
    Laboratory indicators: In rare cases, the appearance of antinuclear antibodies, thrombocytopenia (unusual bleeding and hemorrhage), agranulocytosis, leukopenia, changes in the activity of "liver" enzymes, bilirubin.
    Influence on the fetus: intrauterine growth retardation, hypoglycemia, bradycardia.
    Other: withdrawal syndrome (increased angina attacks, increased blood pressure)
    Admission of the drug Vetchin should be discontinued if one of the above symptoms is observed continuously and its relationship with the use of the drug can not be unequivocally rejected.
    Overdose:
    By toxicity pindolol is one of the least toxic beta-blockers. Toxic symptoms were not observed in any patient who took a single dose of 480 mg.
    Symptoms: severe bradycardia, dizziness, atrioventricular blockade, decreased blood pressure, syncope, ventricular extrasystole, heart failure, cyanosis of the fingernails or palms, convulsions, difficulty breathing, bronchospasm.
    Treatment: intensive therapy and careful monitoring of the patient (blood circulation and respiration parameters, kidney function, blood glucose control, blood serum electrolytes) in combination with conventional nonspecific therapy: remove the non-sucked drug as soon as possible by washing the stomach and taking activated charcoal. With a marked decrease in blood pressure and bradycardia, 0.5-1 mg of atropine can be administered intravenously (higher doses may be administered if necessary); if the desired effect is not achieved, the implantation of a temporary pacemaker is recommended.You can try to stop the effects of competitive beta-adrenergic blockade with isoprenaline infusion (0.5-5 μg / min, not more than 30 μg / min) or dobutamine (2.5-10 μg / kg per 1 min, no more than 40 μg / kg in 1 min.). Inadequate circulation, it is possible to use drugs that increase the intracellular level of cAMP by mechanisms not associated with beta-adrenergic receptors: i.v. injection of 8-10 mg glucagon, which can be repeated after 1 hour and, if necessary, continue by infusion with speed of 1-3 mg / h.
    With bronchospasm you can enter aminophylline intravenous or beta-adrenoceptor stimulant (eg, isoprenaline) by slow intravenous injection or inhalation.
    Interaction:
    Never combine with the following:
    - parenteral blockers of "slow" calcium channels such as phenylalkylamines (verapamil) or benzothiazepines (diltiazem);
    - MAO inhibitors (theoretically, the risk of a pronounced decrease in blood pressure persists for 14 days after the cancellation of the MAO inhibitor).
    Care should be taken when combining with the following:
    - nitrates (risk of arterial hypotension);
    - other antihypertensive agents (especially the groups of guanethidine, reserpine, alpha-methyldopa, nifedipine, clonidine and guanfacine) because of the risk of arterial hypotension and / or bradycardia;
    - clonidine and guanfacine can trigger more severe withdrawal symptoms; therefore, the beta-blocker should be abolished first in such combinations;
    - antiarrhythmics, oral blockers of "slow" calcium channels such as phenylalkylamines (verapamil) or benzothiazepines (diltiazem), parasympathomimetics (risk arterial hypotension, bradycardia and atrioventricular blockade);
    - glycosides of digitalis (risk of bradycardia, conduction disorders; pindolol does not affect the positive inotropic effect of digitalis);
    - by other means having negative inotropic, chronotropic and dromotropic effects (risk of amplification of such effects);
    - ergot alkaloids (risk of peripheral circulatory disorders);
    - drugs that affect the central nervous system (eg, hypnotics, tranquilizers, tri- and tetracyclic antidepressants, neuroleptics) and ethanol (risk of hypertension);
    - phenothiazines and beta-adrenoblockers (increased concentration of each other in the blood plasma);
    - Phenytoin with IV administration and means for general anesthesia (oppression of heart function);
    - α- and β-sympathomimetics (risk of arterial hypertension, severe bradycardia, ability to stop the median);
    - derivatives of xanthines (mutually weaken each other's effects, beta-adrenoblockers can reduce the clearance of theophylline);
    - co-administration with non-steroidal anti-inflammatory drugs (eg, indomethacin) may reduce the hypotensive effect (presumably due to suppression of prostaglandin synthesis in the kidneys, and also sodium and water retention);
    - estrogens weaken the hypotensive effect (Na + delay);
    - oral hypoglycemic agents and insulin (although with a lower probability, pindolol, t. it is a beta-adrenoblocker with CMA, can enhance the hypoglycemic effect of hypoglycemic agents and mask the signs of hypoglycemia if it is recognized only by increased sweating); patients with diabetes, who use pindolol, should learn to recognize hypoglycemic episodes by the occurrence of excessive sweating;
    - inhibitors of enzymes (eg, cimetidine), can increase the level of beta-adrenoblockers in blood plasma and enhance their effects by changing their hepatic metabolism;
    - inducers of enzymes (rifampicin and barbiturates), can weaken the effects of beta-blockers by reducing their concentration in the blood plasma;
    - baclofen (possibly strengthening the hypotensive effect);
    - lidocaine (the concentration of lidocaine in the blood plasma may increase, which increases the risk of side effects on the heart and central nervous system);
    - allergens used for immunotherapy, or allergen extracts for skin tests increase the risk of severe systemic allergic reactions or anaphylaxis in patients receiving pindolol;
    - iodine-containing radiopaque agents (pindolol can suppress compensatory cardiovascular reaction in case of possible shock and arterial hypotension caused by radiocontrast agents; If possible, interrupt the course of pindolol intake before the procedure; if the administration of pindolol is necessary, during the procedure should have funds and personnel for resuscitation);
    - pindolol prolongs the action of nondepolarizing muscle relaxants and anticoagulant effect of coumarins;
    - amifostine (increased risk of severe arterial hypotension or bradycardia);
    - systemic glucocorticosteroids, tetracosactide - with the exception of hydrocortisone in the treatment of Addison's disease (sodium and liquid retention can reduce the hypotensive effect of pindolol).
    - co-administration with antiarrhythmic drugs I (especially quinidine type) or class III can cause a pronounced prolongation of the Q-T interval and severe ventricular rhythm disturbances;
    - Strengthens the action of thyreostatic and uterotonizing drugs; reduces the effect of antihistamines;
    - M-holinoblokatory eliminates the reciprocal increase in activity of the parasympathetic nervous system, which appears against the background of pindolol.
    Special instructions:
    In patients with minor or severe heart failure, the state of compensation should be achieved before the start of the drug. Vetchkin.
    In the acute phase of myocardial infarction or in patients with a history of myocardial infarction, the hemodynamic parameters should be carefully monitored during the administration of Vicin.
    Because of its own sympathomimetic activity (SMA), Pindolol Vecken does not significantly affect respiration in patients with obstructive pulmonary diseases predisposed to bronchospasm. However, such effects can not be completely ruled out, as in the case of the use of other beta-blockers. Therefore, Vekin is contraindicated in patients with bronchial asthma or other obstructive pulmonary disease. When a bronchoconstriction occurs, the use of Vecin should be stopped immediately and appropriate bronchodilator therapy (β2-agonists, theophylline derivatives) applied.
    Before surgery, an anesthesiologist should be warned that the patient is taking Vecin, as cardiac depressant effects that depress the heart, general anesthetics (eg, halothane) may increase.
    If prior to surgery or general anesthesia or for another reason, it is necessary to interrupt the use of the drug Viskin, the dose reduction should be carried out gradually - ideally 1-2 weeks - and if necessary, give a substitute drug,Because the abrupt withdrawal of the drug Visken (especially in patients with coronary heart disease) can worsen the patient's condition and provoke an attack of angina or even myocardial infarction (due to increased activity of beta-adrenergic receptors). If general anesthesia is given on urgent indications after using beta-blockers, careful monitoring of the parameters of the cardiovascular system is necessary, and for the prevention of bradycardia, intravenous injection of 1 to 2 ml of atropine sulfate may be required.
    However, in some cases, the administration of beta-adrenoblockers before surgery may be useful, since they can reduce the arrhythmogenic effects and a decrease in coronary circulation in surgical stress that causes a predominance of sympathetic tone. If, for these reasons, the patient is assigned a beta-blocker, an anesthetic with a weak negative inotropic effect should be chosen to reduce the risk of myocardial depression.
    Despite the fact that due to AGR, the undesirable effect of pindolol on peripheral circulation is less pronounced than that of other beta-blockers without CMA, Viskin should not be administered to patients with severe peripheral vascular occlusive lesions.Care should be taken when treating patients with Raynaud's syndrome. Symptoms (paresthesia and coldness of the lower extremities) of the existing (possibly latent) insufficiency of peripheral circulation may worsen during the administration of the drug Visken.
    With circulatory failure, as well as impaired kidney or liver function, it is especially important to monitor the level of potassium plasma.
    Treatment of patients with diabetes or on a diet requires special care, since pindolol can cause hypoglycemia and mask some of its symptoms (for example, tachycardia), and the only sign of hypoglycemia sometimes remains increased sweating. When prescribing a drug for people with diabetes mellitus, there may be a need for a new correction of carbohydrate metabolism.
    In patients with pheochromocytoma, Vekin should always be combined with alpha-blockers. The patient's existing atrial-ventricular conduction disorders can progress to the condition of the atrioventricular block. Therefore, caution is necessary in the appointment of pindolol to patients with atrioventricular blockade of the I degree.
    In patients who are predisposed to anaphylactic reactions to various antigens, pindolol can enhance anaphylactic reactions. In these cases, higher doses of pressor amines may be required.
    The dose of the drug should be reduced when the heart rate at rest is less than 50 - 55 bpm. and this is accompanied by clinical symptoms.
    Beta-blockers increase the symptoms of psoriasis.
    Athletes should be warned that the active substance of the drug (pindolol) can give a positive result with some doping tests.
    Effect on the ability to drive transp. cf. and fur:
    Viskin can have a negative effect on a patient's ability to drive vehicles or mechanisms, especially at the beginning of the course of treatment and with the concomitant intake of alcohol. Therefore, the degree of the corresponding restrictions is determined for each patient individually, depending on the observed side effects.
    Form release / dosage:
    Tablets 5 mg.
    Packaging:
    For 10 tablets in a blister of PVC / PVDC / al. foil.
    3 blisters together with instructions for use in a cardboard bundle.
    Storage conditions:
    At a temperature of 15-25 ° C and out of reach of children.
    Shelf life:
    5 years.Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:П N013238 / 01
    Date of registration:17.08.2007 / 13.01.2015
    Expiration Date:Unlimited
    Date of cancellation:2018-04-09
    The owner of the registration certificate:Egis Pharmaceutical Plant OJSCEgis Pharmaceutical Plant OJSC Hungary
    Manufacturer: & nbsp
    Representation: & nbspEGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary
    Information update date: & nbsp09.04.2018
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